2-Amino-1,3-propane diol compounds are useful pharmaceuticals which are particularly used as immunosuppressants. 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol hydrochloride belongs to the same class of compounds with the common name as Fingolimod Hydrochloride. 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol hydrochloride (Fingolimod Hydrochloride) is an immunomodulator approved for the treatment of multiple sclerosis (MS) by US FDA in September 2010. Fingolimod hydrochloride is marketed with the trade name Gilenya®. Chemically, Gilenya® is 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol hydrochloride (Formula 1), having a Mol. Wt.: 380.44 and molecular formula: C19H34NO2Cl.

U.S. Pat. No. 5,604,229 discloses the use of 2-amino-1,3-propane diol compounds as pharmaceuticals, in particular immunosuppressants. Said document discloses the synthesis of 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol hydrochloride (Fingolimod Hydrochloride) by various methods and also its use as an immunosuppressant. However, the disclosed synthetic routes for the preparation of Fingolimod Hydrochloride involve tedious column chromatographic purifications along with highly reactive reagents and reactions which are challenging to handle at commercial scales with safety.
US publication No. 2002/0072635 A1 discloses the process for the preparation of 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol hydrochloride involving the reduction of corresponding substituted phenone to the corresponding substituted benzyl alcohol and thereafter reductive deoxygenation of said substituted benzyl alcohol by tedious hydrogenation reaction.
WO 2010/055027 discloses various salts of 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol (Fingolimod) such as tartarate, lactate, benzoate, succinate, malonate, acetate, propionate salts and their corresponding polymorphic forms.
WO 2010/055028 A2 discloses the hydrate and crystalline polymorphs of 2-amino-2-(2-(4-octylphenyl)ethyl)-1,3-propanediol hydrochloride namely, Form-I, Form-II, Form-III.
WO 2011/009634 A2 discloses the process of pharmaceutically acceptable salts of Fingolimod such as ascorbate, succinate, oxalate, phosphate, mandelate, adipate salts and their corresponding polymorphic forms wherein the preparation of said salts involve freeze-drying technique.
Therefore, there is a need in the art to arrive at a robust and commercially viable process for the preparation of Fingolimod and/or its hydrochloride salt wherein the said process is safe, efficacious and does not involve any chromatographic purifications.
The present disclosure aims at overcoming the aforesaid drawbacks of the prior art.